BLA Regulatory Publishing Expert – Veeva eCTD Document Manager

1 day ago

Hyderabad, Telangana, India beBeePublishing Full time ₹ 10,00,000 - ₹ 15,00,000
Regulatory Publishing Specialist

Ensure compliance and quality of regulatory submissions by utilizing Veeva Vault eCTD Publishing to prepare and manage BLA submissions in eCTD format. Compile, format, and publish regulatory documents according to global health authority requirements.

Key Responsibilities:
  1. Submission Preparation: Utilize Veeva Vault eCTD Publishing for preparation and management of BLA submissions.
  2. Document Compilation: Compile, format, and publish regulatory documents according to global health authority requirements.
  3. Compliance Management: Ensure adherence to regulatory guidelines (FDA, EMA) and internal processes.
  4. Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  5. Cross-Functional Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  6. Timely Deliveries: Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
  1. Veeva Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
  2. Regulatory Knowledge: In-depth knowledge of global regulatory requirements (FDA, EMA).
  3. eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  4. Attention to Detail: Excellent organizational skills and attention to detail.
  5. Communication: Good communication skills to collaborate with multiple stakeholders.
  6. Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

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